MAUDE Adverse Event Report: CONMED UTICA SOLID SHAFT ELECTRODE L HOOK 32CM, 5/BOX; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Catalog Number 60-5163-001

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 03/19/2024

Event Type  Injury  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.

Event Description

The sales representative reported on behalf of the customer, that the 60-5163-001, solid shaft electrode l hook 3 was being used during a total laparoscopic hysterectomy procedure on (b)(6) 2024 date when it was reported ¿surgery not delayed but injury to patient.Surgeon had to use ligasure to remove the affected tissue from patient before we continued.¿.Further assessment questioning found ¿the part of surgery where the malfunction took place was the colpotomy.Grey plastic from cautery was adhered to tissue inside abdomen.Plastic and affected tissue were removed from the patient.¿.There was a 5-minute delay reported and the current status of the patient was reported as ¿unsure¿.There was no report of medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported injury due to affected tissue removed from the patient.

Manufacturer Narrative

Received one 60-5163-001 in opened original package.Lot number was verified.Performed a visual inspection, there was visible insulation from the l hook.A root cause cannot be determined, however, based upon the ifu and risk document; a possible cause of this event could be that the device was used for longer operational time frames than advised.It is recommended that a duty cycle of 10 seconds maximum on, and 30 seconds minimum off.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.A two-year lot history review shows a total of 1 device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 1 complaint, regarding 1 device, for this device family and failure mode.During this same time frame 260,955 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.000004.Per the instructions for use, the user is advised to inspect the insulation on the instrument shaft.Do not use an instrument or electrode if the insulation is cracked, or damaged.Select the desired setting for cut or coagulation on the electrosurgical unit.Always use the lowest possible power setting to achieve the desired level of cutting or coagulation of the tissue.This product is designed for non-continuous operation, with a duty cycle of 10 seconds on, and 30 seconds off.The use and proper placement of a patient neutral (dispersive) electrode is a key element in safe and effective electrosurgery.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer, that the 60-5163-001, solid shaft electrode l hook 32cm, was being used during a total laparoscopic hysterectomy procedure on (b)(6) 2024 date when it was reported ¿surgery not delayed but injury to patient.Surgeon had to use ligasure to remove the affected tissue from patient before we continued.¿.Further assessment questioning found ¿the part of surgery where the malfunction took place was the colpotomy.Grey plastic from cautery was adhered to tissue inside abdomen.Plastic and affected tissue were removed from the patient.¿.There was a 5-minute delay reported and the current status of the patient was reported as ¿unsure¿.There was no report of medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported injury due to affected tissue removed from the patient.

• Brand Name: SOLID SHAFT ELECTRODE L HOOK 32CM, 5/BOX
• Type of Device: COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 19116079
• MDR Text Key: 340340238
• Report Number: 1320894-2024-00102
• Device Sequence Number: 1
• Product Code: HFG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K904240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 60-5163-001
• Device Lot Number: 202311131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic